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Trial registered on ANZCTR


Registration number
ACTRN12616001298404
Ethics application status
Approved
Date submitted
26/08/2016
Date registered
15/09/2016
Date last updated
13/12/2019
Date data sharing statement initially provided
16/01/2019
Date results provided
16/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Comparative Study of CMAC D blade versus Glidescope in Simulated Difficult intubations, Using manual inline cervical stabilization on patients with no difficult airway predictors
Scientific title
Randomized Comparative Study of CMAC D blade versus Glidescope in Simulated Difficult intubations, Using manual inline cervical stabilization on patients with no difficult airway predictors
Secondary ID [1] 290023 0
NONE
Universal Trial Number (UTN)
U1111-1183-4062
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 300043 0
Simulated difficult airway management using video laryngoscopes with manual in line axial stabilization on patients coming for elective surgery with no predictors of difficult airway 300045 0
Condition category
Condition code
Anaesthesiology 299941 299941 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CMAC D blade and Glidescope are essentially meant for difficult intubations. In this present study we are comparing these two laryngoscopes in managing the difficult intubations. The limited extension of the neck will be simulated in patients with normal arirway anatomy, using manual in line axial stabilisation (MIAS) manouvre. CMAC D Blade is specially designed blade recommended by the manufacturer in managing the difficult airways. In this study we are testing the efficacy of CMAC D blade against Glidescope. MIAS is applied by an assistant ,standing beside the patient in front of the laryngoscopist with hands placed on the sides of the patient’s head and forearms resting on the patient’s chest. laryngoscopy will be done by single experienced anesthetist of consultant grade. Failure to intubate is defined as time taken to intubation exceeding more than 120 seconds or more than three unsuccessful attempts. The laryngoscopist grade the Intubation difficulty as per the Intubation Difficulty Scale Score (IDS). As per IDS score 0 score will be no difficulty and infinite score is impossible to intubate.
Intervention code [1] 295740 0
Treatment: Devices
Comparator / control treatment
Comparator is Glidescope . Its essentially indirect videolaryngoscope and specially meant for difficult airway management. MIAS manouvre will be employed in this group also
Control group
Active

Outcomes
Primary outcome [1] 299431 0
Intubation difficulty scale score ( IDS)
Timepoint [1] 299431 0
After successful tracheal intubation. The IDS score is graded by the laryngoscopist
Primary outcome [2] 299432 0
Time taken for successful intubation. This is recorded using a stopwatch.
Timepoint [2] 299432 0
The time counted from initial attempts to intubate from the end of bag and mask ventilation till the appearance end tidal carbon dioxide
Secondary outcome [1] 327132 0
Hemodynamic parameters which includes Heart Rate, Systolic Blood Pressure, Diastolic blood pressure and Mean arterial pressure. These parameters are composite measurement. The recording will be done using a multi-parameter monitor which has non invasive blood pressure, ECG, Pulse-oximetry,
Timepoint [1] 327132 0
Pre-induction
Pre-intubation
Post intubation
Post intubation 3 min

Eligibility
Key inclusion criteria
Patients undergoing elective surgery that require general anesthesia with endotracheal intubation.
No predictors for difficult airway: as defined by
Mouth opening more than 4 cms,
Thyromental distance > 6 cms.
Malampati grade 1 and 2.
No documented evidence of difficult airway
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trauma patients
Emergency surgery
Any clinical predictors of difficult airway
Burns patients.
Bronchial asthma, COPD, bronchiectasis
Recent history of chest infection < 4 weeks
Thoracic cage anatomical deformity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Students t test
Fischer Exact test
ANOVA
Chisquare test
Power of the study 80%
Alpha error 5%

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2016
Actual
4/12/2016
Date of last participant enrolment
Anticipated
16/10/2017
Actual
23/09/2018
Date of last data collection
Anticipated
Actual
23/09/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8125 0
Bahrain
State/province [1] 8125 0
Bahrain

Funding & Sponsors
Funding source category [1] 294392 0
Hospital
Name [1] 294392 0
KING HAMAD UNIVERSITY HOSPITAL
Country [1] 294392 0
Bahrain
Primary sponsor type
Individual
Name
SHAHID ADEEL
Address
Consultant
Anesthesia and Pain Medicine
King Hamad University Hospital
PO Box 24343 , Road 2835 Area 228
Muharraq Bahrain
Country
Bahrain
Secondary sponsor category [1] 293240 0
Individual
Name [1] 293240 0
Mahesh Chandrashekaraiah
Address [1] 293240 0
Registrar
Anesthesia and Pain Medicine
King Hamad University Hospital
PO Box 24343 , Road 2835 Area 228
Muharraq Bahrain
Country [1] 293240 0
Bahrain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295814 0
Director of Research and Ethics
Ethics committee address [1] 295814 0
Ethics committee country [1] 295814 0
Bahrain
Date submitted for ethics approval [1] 295814 0
17/05/2016
Approval date [1] 295814 0
24/08/2016
Ethics approval number [1] 295814 0
KHUH/Research/No. 151/2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1073 1073 0 0
/AnzctrAttachments/371379-Acceptance Letter - Dr. Shahid Adeel - CMAC vs Glidescope.pdf (Ethics approval)
Attachments [2] 1127 1127 0 0
/AnzctrAttachments/371379-Acceptance Letter - Dr Shahid Adeel - CMAC vs Glidescope - Title corrected.pdf (Ethics approval)

Contacts
Principal investigator
Name 68574 0
Dr SHAHID ADEEL
Address 68574 0
Consultant Anesthesia and Pain Medicine
King Hamad University Hospital
Area 228 Road 2835 PO Box 24343
Muharraq Bahrain
Country 68574 0
Bahrain
Phone 68574 0
+97317444258
Fax 68574 0
Email 68574 0
shahid.adel@khuh.org.bh
Contact person for public queries
Name 68575 0
Mahesh Madhugiri Chandrashekaraiah
Address 68575 0
Registrar,Anesthesia and Pain Medicine
King Hamad University Hospital
Area 228 Road 2835 PO Box 24343
Muharraq Bahrain
Country 68575 0
Bahrain
Phone 68575 0
+97333520323
Fax 68575 0
Email 68575 0
drmcm@rediffmail.com
Contact person for scientific queries
Name 68576 0
Mahesh Madhugiri Chandrashekaraiah
Address 68576 0
Registrar, Anesthesia and Pain Medicine
King Hamad University Hospital
Area 228 Road 2835 PO Box 24343
Muharraq Bahrain
Country 68576 0
Bahrain
Phone 68576 0
+97333520323
Fax 68576 0
Email 68576 0
drmcm@rediffmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The consent is taken from the patient only to use the data for the study purpose and not to disclose in Public Domain. This Study participants data cannot be disclosed in public domain without the consent and ethics committee approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.